Analytical and Quality Control Lab Manager
- Operations Management: Oversee day-to-day activities, coordinate testing schedules, and manage sample throughput and result reviews for accuracy and trends to meet project deadlines.
- Equipment, Method, & System Validation: Support procurement and validation of equipment as well as transfer and validation of analytical methods to ensure compliance with USP/NF, EU, JP, and other compendial testing requirements.
- Technical Expertise: Provide technical guidance, troubleshoot complex issues, validate and ensure proper calibration and maintenance of instruments (HPLC, GC-MS, etc.). Develop a constant lifecycle of equipment. Develop methods and testing including releasing incoming material testing, in process testing, and final product.
- Quality Systems and Management: Implement and manage Quality Management Systems (QMS) and SOPs, ensure data integrity and that all laboratory records are auditable, accurate. Author and support material specifications as well as SOPs.
- Compliance & Compliance: Ensure adherence to regulatory standards (CLIA, ISO, FDA, ICH, etc.) and function as a subject matter expert during internal/external audits.
- Deviation & CAPA: Lead investigations for out-of-specification (OOS) results, implement Corrective and Preventive Actions (CAPAs).
- Reporting & Communication: Analyze results, prepare detailed reports ( Certificates of Analysis ), and communicate findings to management, clients, and collaborators. Track KPIs, and report on performance, issues, and improvements to management.
- Resource & Budget Management: Manage lab inventory, supplies, equipment procurement, and laboratory budgets effectively. Negotiate with vendors for supplies and service contracts.
- Personnel Management: Recruit, hire, and mentor a team of scientists and technicians. Schedule staff and manage performance through training and career development.
- Safety Oversight: Enforce strict safety protocols, including proper PPE usage and hazardous waste disposal according to OSHA and EPA guidelines.
- Other duties as assigned.
- Bachelor’s degree in chemistry with at least 10 years’ experience.
- 5-7+ years of relevant laboratory experience, with at least 1–3 years in a supervisory or management capacity.
- Proven experience in QC/QA, especially in regulated environments.
- Knowledge of GMP, GDP, ISO, USP/NF, EU, JP, etc. relevant regulations.
- Hands-on expertise with specific analytical techniques (e.g., GC, HPLC, etc.)
- Strong leadership, communication, and organizational skills are critical for managing cross-functional teams and external stakeholders.
- Ability to read, write and communicate in English.
- Master’s or PhD in Chemistry.
- Stand, walk, bend, squat, twist, reach or otherwise move frequently
- Occasional repetitive motion and grasping
- Occasional climbing to reach areas on machines or racks
- Lift, move or otherwise transfer up to 50 lbs. occasionally, >20 lbs. frequently
- Typically sits, grasps items or performs keyboarding for occasional operation of a computer
- Exposure to typical machine shop physical hazards which may require respiratory protection
- Clean, Climate-Controlled Environment
- Stable schedule
- Paid holiday and PTO
- Health, dental, and vision insurance
- 401(k) retirement savings
- Life and disability insurance
- Promotional opportunities
- Training and career growth programs
- Amazing co-workers
- Tuition reimbursement
- Employee Assistance Program
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